利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.133181833185703183413182003183463183280.05
210.183176653174603175620.05
单位质量响应值RSD%判断
31424.2831194.700.52数据可信
供试品溶液-2024122721批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198858-9885828.30427.785.1028.3027.785.11
2101203-10120328.97528.98
398721-9872128.26428.26
493704-9370426.82826.83
5101137-10113728.95628.96
688619-8861925.37225.37
10min1141653-14165340.55640.861.3340.6040.901.33
2142830-14283040.89340.94
3141578-14157840.53540.58
4141472-14147240.50440.55
5146407-14640741.91741.97
6142269-14226940.73340.77
15min1167176-16717647.86448.121.2947.9848.231.30
2167730-16773048.02248.14
3166125-16612547.56347.68
4166044-16604447.54047.65
5171519-17151949.10749.23
6169734-16973448.59648.71
20min1183231-18323152.46053.061.2852.6553.261.28
2184739-18473952.89253.09
3183547-18354752.55152.74
4183863-18386352.64152.83
5188362-18836253.92954.13
6188287-18828753.90854.10
30min1205918-20591858.95659.310.8559.2459.590.84
2206581-20658159.14659.43
3205747-20574758.90759.19
4206185-20618559.03259.31
5210135-21013560.16360.45
6208375-20837559.65959.94
45min1227205-22720565.05065.280.6265.4365.660.62
2228430-22843065.40165.78
3227583-22758365.15965.54
4226229-22622964.77165.15
5230386-23038665.96166.35
6228266-22826665.35465.73
60min1238995-23899568.42668.800.4568.9169.290.45
2240275-24027568.79269.28
3240607-24060768.88769.38
4239897-23989768.68469.17
5242153-24215369.33069.83
6239817-23981768.66169.15
极限1250339-25033971.67471.750.3372.2872.360.33
2251739-25173972.07572.68
3251136-25113671.90272.51
4249689-24968971.48872.09
5250979-25097971.85772.47
6249765-24976571.50972.11
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.133180183181523184373181773175763180720.10
210.183173353178573175960.12
单位质量响应值RSD%判断
31399.0131198.040.46数据可信
供试品溶液-2024122721批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193703-9370326.83725.926.0826.8425.926.08
282436-8243623.61023.61
392573-9257326.51326.51
485797-8579724.57324.57
597507-9750727.92727.93
690955-9095526.05026.05
10min1145450-14545041.65840.851.5341.7040.901.52
2142372-14237240.77640.82
3141420-14142040.50440.55
4143323-14332341.04941.09
5144015-14401541.24741.29
6139217-13921739.87339.92
15min1170877-17087748.94048.201.5249.0548.311.51
2170014-17001448.69348.80
3166419-16641947.66347.78
4170531-17053148.84148.95
5167338-16733847.92748.04
6164642-16464247.15447.26
20min1186970-18697053.54953.051.5153.7553.251.51
2188033-18803353.85454.04
3183361-18336152.51652.71
4188086-18808653.86954.06
5183357-18335752.51552.71
6181643-18164352.02452.21
30min1208232-20823259.63959.321.1659.9259.601.15
2209358-20935859.96160.24
3206270-20627059.07759.36
4209888-20988860.11360.39
5204879-20487958.67958.96
6204119-20411958.46158.74
45min1227733-22773365.22465.010.8865.6165.390.88
2229213-22921365.64866.03
3226935-22693564.99665.37
4228808-22880865.53265.91
5224652-22465264.34264.72
6224611-22461164.33064.70
60min1239329-23932968.54568.440.8069.0468.920.80
2241605-24160569.19769.68
3239057-23905768.46768.95
4240120-24012068.77269.26
5236451-23645167.72168.21
6237110-23711067.91068.39
极限1249631-24963171.49671.450.6272.1072.050.62
2251770-25177072.10872.71
3249973-24997371.59472.19
4249861-24986171.56272.17
5247353-24735370.84371.44
6248248-24824871.10071.69
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.134894224897434905254902194897684899350.09
210.184891094892274891680.02
单位质量响应值RSD%判断
48364.7648051.870.46数据可信
供试品溶液-2024123021批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1124096-12409623.07523.862.1723.0823.862.17
2127373-12737323.68423.68
3127239-12723923.65923.66
4131694-13169424.48824.49
5131025-13102524.36324.36
6128340-12834023.86423.86
10min1182446-18244633.92534.221.2133.9634.261.21
2182970-18297034.02234.06
3182941-18294134.01734.06
4186217-18621734.62634.67
5182156-18215633.87133.91
6187438-18743834.85334.89
15min1211881-21188139.39839.520.9939.4939.620.99
2212968-21296839.60039.70
3211737-21173739.37139.47
4214692-21469239.92140.02
5209234-20923438.90639.00
6214778-21477839.93740.03
20min1230869-23086942.92942.950.9643.0943.110.95
2231476-23147643.04243.20
3231150-23115042.98143.14
4232379-23237943.21043.37
5226858-22685842.18342.35
6233224-23322443.36743.53
30min1253006-25300647.04546.850.7747.2847.080.77
2252542-25254246.95947.19
3252955-25295547.03647.27
4252604-25260446.97047.21
5248032-24803246.12046.35
6252449-25244946.94247.18
45min1269469-26946950.10650.000.6750.4250.320.66
2269396-26939650.09350.41
3269399-26939950.09350.41
4270911-27091150.37550.69
5265607-26560749.38849.70
6268660-26866049.95650.27
60min1278665-27866551.81651.570.5052.2151.960.49
2278079-27807951.70752.10
3277499-27749951.60051.99
4278324-27832451.75352.15
5275053-27505351.14551.54
6276445-27644551.40451.80
极限1285055-28505553.00552.730.5953.4953.210.59
2284588-28458852.91853.40
3283789-28378952.76953.25
4284889-28488952.97453.46
5281261-28126152.29952.78
6281742-28174252.38952.87
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.134898884898884894044896754886614895030.11
210.184874204873224873710.02
单位质量响应值RSD%判断
48322.1147875.340.66数据可信
供试品溶液-2024123021批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130188-13018824.26324.112.1524.2624.102.15
2133239-13323924.83224.83
3131716-13171624.54824.55
4126951-12695123.66023.66
5127201-12720123.70723.71
6126740-12674023.62123.62
10min1185641-18564134.59835.021.7534.6435.061.75
2190165-19016535.44135.48
3192225-19222535.82535.87
4189357-18935735.29135.33
5183330-18333034.16734.21
6186600-18660034.77734.82
15min1213387-21338739.76940.151.4239.8740.251.42
2215388-21538840.14240.24
3220110-22011041.02241.12
4217659-21765940.56540.66
5211614-21161439.43939.54
6214357-21435739.95040.05
20min1230932-23093243.03943.331.2543.2043.491.25
2232596-23259643.34943.52
3236707-23670744.11544.28
4234531-23453143.71043.88
5228339-22833942.55642.72
6231776-23177643.19643.36
30min1251075-25107546.79346.960.7947.0347.200.80
2250968-25096846.77347.01
3255472-25547247.61247.86
4253010-25301047.15447.39
5249976-24997646.58846.82
6251374-25137446.84947.08
45min1267423-26742349.84049.890.4850.1550.200.49
2267250-26725049.80850.13
3270072-27007250.33450.66
4267911-26791149.93150.25
5266435-26643549.65649.97
6266899-26689949.74250.06
60min1275722-27572251.38751.420.4151.7851.820.42
2275170-27517051.28451.68
3277949-27794951.80252.21
4276351-27635151.50451.90
5275135-27513551.27751.67
6274992-27499251.25051.65
极限1282491-28249152.64852.510.3353.1353.000.34
2281297-28129752.42652.91
3282467-28246752.64453.14
4282389-28238952.62953.12
5281847-28184752.52853.01
6280150-28015052.21252.69
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